Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases (NCT05996354) | Clinical Trial Compass
UnknownNot Applicable
Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases
China10 participantsStarted 2022-03-01
Plain-language summary
There are no endoluminal stent systems available on the Chinese market for the effective treatment of aortic arch lesions (involving aortic arch aneurysms, aortic coarctation, aortic pseudoaneurysms, aortic ulcers, and intermural hematomas), and therefore this study is intended to be a prospective, single-arm study.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who are ≥ 18 years old and ≤ 85 years old；
. Patients with aortic arch diseases (involving aortic arch aneurysm, aortic dissection, aortic pseudoaneurysm, aortic ulcer, and intermural hematoma);
. Anatomical criteria, including:
. Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
. The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 15 mm;
. The diameter of the anchored area of the innominate artery is between 10-16 mm, the diameter of the anchored area of the left common carotid artery is between 5-12 mm, and the diameter of the anchored area of the left subclavian artery is between 5-12 mm. Anchorage zone length is greater than or equal to 15 mm;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Immediate technical success rate
Timeframe: Immediate intraoperative
Trial details
NCT IDNCT05996354
SponsorChina National Center for Cardiovascular Diseases
. Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;
. Have a suitable iliac, femoral, and superior arch arterial approach;
Exclusion criteria
. Patients with general or local infections that may increase the risk of endovascular graft infection;
. Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to make the stent-graft difficult to adhere to or affect the patency of the stent;
. Patients with neck vascular surgery within 3 months;
. Patients with severe carotid or subclavian artery stenosis, calcification;
. Patients with a history of acute coronary syndrome within 6 months:
. Patients with transient ischemic attack (TIA) or ischemic stroke within 3 months;
. Patients with preoperative hepatic and renal dysfunction, \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded the upper limit of normal level by a factor of five; Serum creatinine (Cr) \>150umol/L\];
. Patients with history of bleeding or coagulopathy, who cannot receive antiplatelet therapy;